Families Moving Forward Bridges: An Early Intervention for Infants and Toddlers With PAE With or At-risk for FASD

July 24, 2025 updated by: Tracy Jirikowic, University of Washington

Families Moving Forward Bridges: An Early Intervention Enhancement for Infants and Toddlers With Prenatal Alcohol Exposure With or At-risk for Fetal Alcohol Spectrum Disorders

This is an unblinded, feasibility study of an adapted positive parenting intervention to be carried out in a small sample (n=12 dyads) of young children with FASD and their primary caregiver in King County, WA.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This is an initial feasibility study to examine Families Moving Forward Bridges (FMF Bridges), an FASD-informed early intervention designed to meet the specific needs of young children 6-36 months with prenatal alcohol exposure (PAE) or FASD and their caregivers. FMF Bridges was developed by this research team and is adapted from a scientifically-validated positive parenting intervention (Families Moving Forward) shown to be efficacious with preschool and school-aged children affected by PAE or FASD. FMF Bridges merges key components of FASD-informed care with family-centered and relationship-based early intervention practices and is designed to be delivered in community-based early intervention programs. The FMF Bridges early intervention needs to be tested with children and families in the community-based early intervention settings for which it was designed. The study team plans to evaluate the feasibility of FMF Bridges in a small community trial. the team will partner with an early intervention program that has a high population of children with prenatal alcohol exposure. EI providers will be trained as FMF Bridges Specialists and deliver the intervention to a total of 12 dyads (young child and their primary caregiver). Dyads will receive ten 60-minute manualized FMF Bridges intervention sessions over 3-5 months (approximately every other week) from community EI providers trained as FMF Bridges Specialists.

Primary Aim 1: Examine the feasibility of implementing the FMF Bridges early intervention in a community early intervention setting.

The study will focus on answering the questions: 1) Is it practical to implement the FMF Bridge intervention in a community EI setting? 2) Can the intervention be implemented with fidelity? 3) Is the intervention acceptable to providers and caregivers? and 4) What refinements might be needed to improve the feasibility of implementation?

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Shoreline, Washington, United States, 98177
        • Wonderland Child Development Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Child inclusion criteria: Infants and toddlers 6-36 months of age, any gender, any race/ethnicity, who:

    1. have confirmed PAE as ascertained by the standard child development center intake procedures;
    2. and 2) qualify for IDEA Part C EI services based on presence of a developmental delay (>25% in one or more areas of development) or therapist/provider informed clinical opinion.

Caregiver inclusion criteria:

  1. biological, foster, adoptive, or other legal guardian;
  2. age 18 or older;
  3. any gender.

Exclusion Criteria:

  • Child exclusion criteria:

    1. child has lived with current caregiver for less than 30% of chronological age or there is a planned change in caregiver placement or move out of King County within 3 months of intake;
    2. child has a medical or congenital/genetic condition that would severely limit participation in assessments, such as a significant visual or hearing impairment, degenerative muscle condition, or uncontrolled seizures;
    3. multiple birth;
    4. child currently receives inpatient medical care (e.g., NICU) or has a medical condition requiring a planned inpatient hospitalization or surgical intervention (e.g., heart condition);
    5. child diagnosis of a known genetic or non-FASD neurodevelopmental condition (e.g., Down syndrome, autism spectrum disorder).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FMF Bridges Early Intervention Program
Following enrollment, a baseline assessment session will be completed (see caregiver and child assessments document uploaded). Following the assessment, the caregiver will receive intervention services from a trained FMF Bridges Specialists from Wonderland Child and Family Services within 1 month of completing the baseline assessment. The trained EI providers will deliver the FMF Bridges intervention, comprised of 10, 60-minute manualized intervention sessions (see FMF Bridges Intervention Protocol and Materials document). Sessions are expected to be delivered weekly or bi-weekly in the home (the standard of care for EI services), over a 3-to-5-month time period, with those electing to complete weekly sessions taking approximately 3 months or up to 5 for those who choose biweekly sessions. Outcome measures will be immediately post-intervention, as close as possible to the last session, and within 1 month of completing the intervention. Outcome measures at baseline and post interventio
Behavioral: Families Moving Forward Bridges
Ten, 60-minute manualized FMF Bridges intervention sessions over 3-5 months (approximately every other week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Devereux Early Childhood Assessment-Infant/Toddler (DECA-IT)
Time Frame: From enrollment to the end of intervention 3-5 months
Standardized parent rating scale assessing child initiative, attachment, and self-regulation. Internal consistency (α=.90-.94); test-retest reliability (r= .91-.99).
From enrollment to the end of intervention 3-5 months
Parenting Interactions with Children - Checklist of Observations Linked to Outcomes (PICCOLO) 86
Time Frame: From enrollment to the end of intervention 3-5 months
An observational measure of caregiver behavior including affection, responsiveness, encouragement, and teaching through caregiver-child interactions. Internal consistency (α=.75-.80); interrater reliability (r= .74-.80); construct validity (r= .62).
From enrollment to the end of intervention 3-5 months
Family Outcomes Survey - Revised (FOS-R)
Time Frame: From enrollment to the end of intervention 3-5 months
Designed to measure family outcomes and helpfulness of early intervention. Parent survey to rate the extent to which they have achieved family outcomes including knowing their rights and advocate effectively for their child, understand their child's strengths and needs, help their child develop and learn, have support systems, and access desired community services, programs, and activities.
From enrollment to the end of intervention 3-5 months
Healthy Families Parenting Inventory (HFPI)
Time Frame: From enrollment to the end of intervention 3-5 months
Designed to measure outcomes in home visitation programs. A survey of multiple dimensions of parenting: parent social support, problem solving, depression, personal care, mobilizing resources, role satisfaction, parent-child interactions, the home environment and parenting efficacy. Good internal consistency; evidence for convergent validity.
From enrollment to the end of intervention 3-5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Tracy Jirikowic, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

March 14, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00020599
  • 1R61AA031695-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share the statistical analysis plan. We will not share informed consent or study protocol because this is a feasibility study with a small sample.

IPD Sharing Time Frame

Data will become available after analysis is complete. Following the conditions and timeline in the NIMH data archive.

IPD Sharing Access Criteria

Individual level data deidentified will be shared in the NIMH Data Archive.

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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